{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SUNNYVALE", "manufacturer_contact_address_1": "1266 KIFER RD, BLDG 101", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2010-00460", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20101025", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94086", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "UYESUGI", "source_type": [ "Foreign", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94086", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20101026", "manufacturer_contact_f_name": "NICKY", "device_date_of_manufacturer": "20070601", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20101025", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;07/23/2025", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20101025", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU", " DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "80 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20100926", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "1882154", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94086", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC.,", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "1836289", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00461 AND 2955842-2010-00462." }, { "mdr_text_key": "1850979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2011, THE INITIAL REPORTER PROVIDED ADDITIONAL INFORMATION RELATED TO THIS EVENT. HE ADVISED THAT THE PATIENT HAD A HISTORY OF PULMONARY AND CARDIAC PROBLEM TO SURGERY AND REFUSED A TRACHEOTOMY POST DA VINCI S PARTIAL LARYNGECTOMY PROCEDURE. THE PATIENT EXPIRED APPROXIMATLEY 1 MONTH POST OP SECONDARY TO A PULMONARY INFECTION DUE TO THE ASPIRATIONS. THE INITIAL REPORTER ADVISED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM." }, { "mdr_text_key": "8890172", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SURGEON HAS INDICATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED. AS OF OCTOBER 22, 2010, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO INTUITIVE SURGICAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1266 KIFER RD, BLDG 101", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94086", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/01/2011;08/06/2025" } ] }